BEUDAMED
    FDA Recall Terminated

    EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    Recall: Z-0364-2019 · Initiated September 12, 2018

    Recall

    Recall Number
    Z-0364-2019
    Event Number
    81240
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 12, 2018
    Posted
    November 2, 2018
    Terminated
    November 2, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    Reason

    Potential ability to leak once used for compounding.

    Action

    An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail. Baxter is asking customers to: 1. Locate and remove all affected product from your facility. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email. Notification Effectiveness: 100%. The non-responding customers will be contacted via telephone. Expansion on 02/19/2019, Baxter notified customers (and additional customers) of recall and additional lots included.

    Distribution

    Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.

    Quantity

    110,134 units